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RECRUITING
NCT04077307
PHASE1

A Study in Leukemia Patients With Karonudib

Sponsor: Thomas Helleday Foundation

View on ClinicalTrials.gov

Summary

The primary objective of this study is to determine safety and tolerability of Karonudib for the treatment of hematological malignancies. Secondary objectives are to determine a recommended RP2D and schedule for further development of Karonudib, to determine the pharmacokinetics of Karonudib, to look for evidence of treatment efficacy. Overall survival will also be recorded.

Official title: A Phase 1 Study in Patients With Hematological Malignancies to Evaluate Safety, Tolerability and Efficacy of Karonudib

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2019-12-03

Completion Date

2026-12-30

Last Updated

2025-12-19

Healthy Volunteers

No

Conditions

Interventions

DRUG

Karonudib

First part of the study - four different dose cohorts Extension part of the study - karonudib BID (twice a week) and Idarubicin days 1-3.

Locations (6)

Aarhus University Hospital

Aarhus, Denmark

Rigshospitalet Copenhagen University Hospital

Copenhagen, Denmark

University Clinical Center Belgrade

Belgrade, Serbia

University Clinical Center Kragujevac

Kragujevac, Serbia

Karolinska University Hospital

Huddinge, Sweden

Örebro University Hospital

Örebro, Sweden